NDC 42385-913

Emtricitabine and Tenofovir Disoproxil Fumarate

Emtricitabine And Tenofovir Disoproxil Fumarate

Emtricitabine and Tenofovir Disoproxil Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Emtricitabine; Tenofovir Disoproxil Fumarate.

Product ID42385-913_123cc339-261f-48d8-85e1-838fc48d3f7f
NDC42385-913
Product TypeHuman Prescription Drug
Proprietary NameEmtricitabine and Tenofovir Disoproxil Fumarate
Generic NameEmtricitabine And Tenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-26
Marketing CategoryANDA / ANDA
Application NumberANDA212114
Labeler NameLaurus Labs Limited
Substance NameEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength200 mg/1; mg/1
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42385-913-30

30 TABLET, FILM COATED in 1 BOTTLE (42385-913-30)
Marketing Start Date2019-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42385-913-30 [42385091330]

Emtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212114
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-26

NDC 42385-913-90 [42385091390]

Emtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212114
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-26

Drug Details

Active Ingredients

IngredientStrength
EMTRICITABINE200 mg/1

OpenFDA Data

SPL SET ID:4a7ccbbf-da20-4012-9717-31c411efb3fb
Manufacturer
UNII

Pharmacological Class

  • Nucleoside Analog [EXT]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleosides [CS]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
  • Nucleosides [CS]
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC Crossover Matching brand name "Emtricitabine and Tenofovir Disoproxil Fumarate" or generic name "Emtricitabine And Tenofovir Disoproxil Fumarate"

NDCBrand NameGeneric Name
0093-7607Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
0093-7704Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
0378-1930Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
0904-7172Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
16714-534Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
31722-560Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
33342-106Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
42291-439Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
42385-913Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
42385-953Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
42543-719Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE and TENOFOVIR Disoproxil Fumarate
50090-5957EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
51407-112Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE and TENOFOVIR Disoproxil Fumarate
60219-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
60219-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
60219-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
60505-4202Emtricitabine and Tenofovir Disoproxil Fumarateemtricitabine and tenofovir disoproxil fumarate
69238-1547Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-1527Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-1548Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-1549Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
69238-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
72189-156EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
69238-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
35356-070Truvadaemtricitabine and tenofovir disoproxil fumarate
50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarate
52959-969Truvadaemtricitabine and tenofovir disoproxil fumarate
53808-0805Truvadaemtricitabine and tenofovir disoproxil fumarate
61919-669TRUVADAemtricitabine and tenofovir disoproxil fumarate
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarate
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